Evaluate the Influence of Electromagnetic Field as an Adjunctive Non Surgical Treatment in Implant With Peri-implantitis

Not Applicable

Completed

• Conditions: Peri-Implantitis
• Interventions: Device: Magdent Cap MED; Device: Sham MED

• Registration Number: NCT04213144
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

the aim of the study is to compare between two non-surgical methods of treatment of peri-implantitis by using debridement and placing an healing abutment with electomagnetic field (MED-Magdent Miniaturized Device) in the test group and Sham healing abutment in the control group ( Sham MED).

Detailed Description

Dental Implants are common alternative for replacement at the time of tooth loss. The two common methods for treatment implant with inflammation include surgical and global non-surgical treatment.

The non-surgical treatment includes soft tissue debridement with various tools which including manual, ultrasonic rotators, lasers and delayed release devices.

Using an electromagnetic field to induce bony healing in fractures and around implants is being investigated for studies and was found to be effective and safe. The electric field lowers osteoclasts activity, speeds up osteoid construction and stimulates creation blood vessels development. Forty patients who will attend to the department of periodontology at Rambam health care campus, at the School ofpostgraduate Dentistry, which will meet the research criteria, will be recruited. All patients will exhibit a moderate-onset gum infection around one of the implants.

Study Timeline

• Study First Submitted: 2019-12-25
• Study First Submitted QC: 2019-12-25
• Study First Posted: 2019-12-30
• Study Start: 2020-03-03
• Primary Completion: 2022-10-19
• Study Completion: 2022-10-19
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-02
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Written informed consent.
• Patients of 20 - 85 years.
• pocket depth of 5-8 mm and bone loss of 3-5mm Patients with fixed prosthodontics Implant with standart width

Exclusion Criteria

• Heavy smokers (more than 10 cigarettes per day).
• Pregnant women
• active periodontal disease
• Consumption of Non Steroidal Anti Inflammatory drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magdent Cap MED	Magdent Cap MED	Soft and hard tissue healing with electomagnetic healing abutment.
Sham MED	Sham MED	Soft and hard tissue healing with a regular healing abutment.

Primary Outcome Measures

Name	Time	Method
Change in the implant probing depth (IPD)	baseline, 4 weeks, 12 weeks	clinical measurement of the depth of the pocket around the implant in 6 sites

Secondary Outcome Measures

Name	Time	Method
changing in the concentration of the RANKL cytokine	baseline, 2 weeks, 4 weeks, 12 weeks	Sampling the amount bycollecting gingival fluid with paper pins and examining the amount of the cytokine with ELISA (Enzyme Linked Immunoflorecance assay)asay

Trial Locations

Locations (1)

Rambam Health Care Campus, Dept. of Periodontology; 🇮🇱 Haifa, Israel